# K162512: truSculpt

- Pathway: 510(k) (Traditional)
- Applicant: Cutera, Inc.
- Decided: Dec 9, 2016 after 92 days
- Product code: PBX (Massager, Vacuum, Radio Frequency Induced Heat)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K943450 (1995). 107 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 113 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133739: Trusculpt, Cutera, Inc. (2014) Summary page 4.
- K143559: XP1000 RF, BTL Industries, Inc. (2015) Summary page 4.
- K120510: Transcend, Syneron Medical, Ltd. (2013) Summary page 4.

## Most influential descendants
- K180709: truSculpt RF Device; truSculpt; truSculpt 3D (2018), 3 descendants of its own
- K172004: truSculpt (2017), 3 descendants of its own
- K221407: truSculpt iD (2022), 2 descendants of its own
- K223110: truSculpt iD (2022), 1 descendant of its own
- K252888: NeoSculpt Plus (2026), 0 descendants of its own

## Indications for use
The truSculpt RF energy is intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions, such as relief of pain and muscle spasms and increase in local circulation. Additionally, the 2 MHz setting for the 40 cm2 handpiece is indicated for temporary reduction in circumference of the abdomen. The truSculpt massage device is intended to provide a temporary reduction in the appearance of cellulite.

Source page: https://510kreport.com/device/K162512
Methodology: https://510kreport.com/methodology